check_circleStudy Completed

Contraception

Bayer Identifier:

91555

ClinicalTrials.gov Identifier:

NCT00910637

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

Trial purpose

This study is examining a birth control patch for 13 cycles (1 year).

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - Requiring contraception
    - Normal cervical smear
    - Maximum age for smokers is 35
    - History of regular cyclic menstrual periods
  • - Pregnancy or lactation
    - Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
    - Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
    - Use of other contraceptive methods than study medication

Trial summary

Enrollment Goal
1502
Trial Dates
May 2009 - December 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Chattanooga, 37404, United States
Completed
Philadelphia, 19114, United States
Completed
Precision TrialsPhoenix, 85032, United States
Completed
Rosemark Women Care SpecialistIdaho Falls, 83404, United States
Completed
Visions Clinical ResearchBoynton Beach, 33472-2952, United States
Completed
South Bend, 46601, United States
Completed
Boston, 02118, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Corpus Christi, 78414, United States
Completed
Winston-Salem, 27103, United States
Completed
San Diego, 92108, United States
Completed
Albuquerque, 87102, United States
Completed
Miami, 33186, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
Portland, 97239-3011, United States
Completed
Jacksonville, 32207, United States
Completed
Mt. Pleasant, 29464, United States
Completed
Decatur, 30034, United States
Completed
New Bern, 28562, United States
Completed
Columbus, 43213, United States
Completed
San Diego, 92123, United States
Completed
Newburgh, 47630, United States
Completed
Moorestown, 08057, United States
Completed
Office of Dr. R. Garn Mabey, MDLas Vegas, 89128, United States
Completed
Chaska, 55318, United States
Completed
Marrero, 70072, United States
Completed
Columbia, 29201, United States
Completed
Las Vegas, 89106, United States
Completed
Glendale, 85304, United States
Completed
Roswell, 30075, United States
Completed
Winston-Salem, 27103, United States
Completed
Denver, 80218, United States
Completed
New York, 10032, United States
Completed
Women's Care Center, PLCMemphis, 38119, United States
Completed
Lincoln, 68510, United States
Completed
Research AssociatesBoise, 83702, United States
Completed
Carmichael, 95608, United States
Completed
Knoxville, 37920, United States
Completed
Las Vegas, 89030, United States
Completed
Women's Clinical Research CenterSeattle, 98105, United States
Completed
Torrance, 90502, United States
Completed
Chicago, 60612, United States
Completed
Pacific Palisades, 90272, United States
Completed
Lawrenceville, 08648, United States
Completed
Paramount, 90723, United States
Completed
Littleton, 80122, United States
Completed
Cleveland, 44122, United States
Completed
Warwick, 02886, United States
Completed
Nashville, 37203, United States
Completed
Birmingham, 35235, United States
Completed
Meridien ResearchSt. Petersburg, 33709, United States
Completed
Pittsburgh, 15213, United States
Completed
Atlanta, 30328, United States
Completed
Eugene, 97401, United States
Completed
The Woman's Hospital of TexasHouston, 77054, United States
Completed
Cincinnati, 45267-0457, United States
Completed
Norfolk, 23507, United States
Completed
Nashville, 37205, United States
Completed
Advances in Health, inc.Houston, 77030, United States
Completed
Pembroke Pines, 33024, United States
Completed
Santa Ana, 92705, United States
Completed
New London, 06320, United States
Completed
Practice Research OrganizationDallas, 75230, United States
Completed
York Clinical ConsultingOklahoma City, 73120, United States

Primary Outcome

  • Occurrence of pregnancy (yes/no) while on treatment
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days and follow-up period of 14 days
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Vital signs
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes
  • Physical and gynecological examinations
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes
  • Laboratory assessments
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events (AE monitoring)
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Multicenter, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene in a 21-day regimen for 13 cycles in 1650 healthy female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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